Quality Control Analyst III

Company: Yoh, A Day & Zimmermann Company
Location: Somerville
Posted on: April 10, 2021

Job Description:

**Ability to travel between Norton, MA and Cambridge, MA sites**



Summary of Key Responsibilities


Performance of moderate to complex QC testing for raw material, in-process, release, and stability in accordance with turn-around time requirements and KPI.
May support raw material testing, inspection, and release process.

Demonstrated knowledge of analytical testing (U/HPLC, LC-MS, GC, KF, spectroscopy,
etc.) to support method implementation and routine testing.
Leads phase appropriate technology transfer, feasibility, method transfer, and method validation.
Assist in the support and management of laboratory equipment lifecycle management by implementing new technology/instrumentation in the QC laboratory and ensuring existing instrumentation are maintained to standard.
Peer review data related to testing and laboratory operations (i.e., investigations, equipment qualifications, etc.).
Author and review technical documentation (e.g. SOPs, protocols, reports) with guidance commensurate with experience.
Troubleshoot routine problems related to laboratory procedures, assay performance, instrumentation, and data with guidance commensurate with level; provide recommendations to non-routine issues.
Contribute substantially to interpretation of data including trending of analyses, investigations (OOS, atypical, out of trend, MDN), and design of experimentation.
Conduct and support investigations and changes through the Alnylam electronic management system driving and supporting completion of formal root cause analyses, deviations, change control, CAPA and effectiveness checks.

Conduct and support continuous improvement efforts of operation systems (i.e., automation, efficiency, reduction of waste)
Ensures continuous GMP-compliant state of the QC laboratories. May participate in audit and inspection activities.
Collaborate with internal departments efficiently and effectively (e.g. Manufacturing, Quality Assurance, Process Sciences, Analytical Sciences, and Regulatory Affairs)
Promote Safe, positive, and compliance-driven work environment





Qualifications


Minimum education required for this position is a Bachelor of Science Degree in a scientific discipline (e.g. Analytical Chemistry, Biochemistry, Chemistry, Biology, etc.).
Minimum experience required for this position is 4-6 years of experience in a GMP laboratory.
Experience with QC analytical testing platforms (U/HPLC on Empower, LC-MS, GC, Karl Fisher, ICP-OES, spectroscopy, etc.); raw materials (sampling/testing) experience and microbiology experience desirable but not required.
Knowledge of and ability to interpret USP, Ph. EUR, JP, and ICH guidelines is desirable
Experience with laboratory equipment lifecycle management processes for URS and IQ/OQ/PQ required; familiarity with data integrity and laboratory software validation is desired.
Experience/Familiarity with LIMS, in particular LabWare LIMS, is desired.
Ability to travel between domestic sites is required (Norton, MA; Cambridge, MA).


Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.PandoLogic.Category: Quality Control, Keywords: Quality Control / Quality Assurance Analyst

Keywords: Yoh, A Day & Zimmermann Company, Somerville , Quality Control Analyst III, Professions , Somerville, Massachusetts